FDA hits CDMO Ei for making drugs and pesticides with same equipment


The FDA hit Ei, a CDMO, with a warning letter for manufacturing pharmaceuticals in the same building and with the same equipment it uses to produce pesticides.

In its letter posted to the regulatory agency’s website, the FDA outlined poor manufacturing procedures at the company’s facility located in Kannapolis, North Carolina. The plant, which produces finished pharmaceuticals like liquid and semisolid topical drugs, was inspected in early October 2017.

The agency said inspectors found the company “manufactured topical human drugs and several pesticides in the same building, using shared equipment” despite the risk of cross contamination. Inspectors also found two of the drugs meant for human use contained a pesticide produced at the facility.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

Additionally, the agency said Ei didn’t have or follow correct procedures for cleaning and maintaining the equipment, and failed to investigate any “unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.”

“Our investigator also found evidence of contamination from unknown impurities in six engineering batches of clobetasol propionate 0.05% topical spray,” the agency wrote. “You produced these drug products using the same equipment and facilities that you use for commercial manufacturing.”

The FDA recommended Ei hire an outside consultant to help them with the issues.



Source link

Leave a Reply

Your email address will not be published.